Bronchotracheal access valve for a bronchoaspiration apparatus

ABSTRACT

A bronchotracheal access valve for a bronchoaspiration apparatus. The valve is characterized in that the rotation of a second member in a given direction with respect to a first member moves the valve from a configuration in which a conduit communicates hydraulically with a sleeve, to a configuration in which the conduit communicates hydraulically with a flush conduit via a duct and a channel to flush an end portion of a catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No. 11/917,339 filed Dec. 12, 2007, which is a U.S. national stage application of International Application No. PCT/EP2006/005623 filed Jun. 12, 2006, which designates the United States of America, and claims priority to Italian application number BO2005A000404 filed Jun. 15, 2005, the contents of which are hereby incorporated by reference in their entirety.

BACKGROUND

The present invention relates to a bronchotracheal access valve for a bronchoaspiration apparatus.

As is know, a bronchoaspiration apparatus, connectable to a ventilation circuit, comprises”

-   -   a vacuum generating and regulating device,     -   a catheter body comprising a transparent sleeve and a catheter;         and     -   a bronchotracheal access valve connected mechanically to a         connecting member for connection to a patient's body.

A bronchoaspiration apparatus must ensure complete isolation of the suction catheter from the environment, to prevent contamination of the patient by the environment and vice versa, i.e. contamination of the environment by the patient.

In operation, after a first suction stage, the end portion of the catheter is normally flushed by injecting sterilized water or a saline solution through a passage provided for that purpose.

The flushing operation is potentially hazardous to the patient, particularly in the case of babies. That is, the operator may inadvertently inject the flush fluid without activating the flush fluid suction means; in which case, the flush fluid would flow directly into the patient's trachea, thus resulting in obvious damage, which is particularly serious in the treatment of babies.

SUMMARY

It is therefore a main object of the present invention to provide a bronchotracheal access valve (for a bronchoaspiration apparatus) designed to only permit flushing of the end of the catheter in given patient safety conditions. Consequently, any inadvertent action possibly resulting in flush fluid being injected into the patient's trachea is prevented, even if the bronchotracheal access valve is in the open position.

It is therefore a main object of the present invention to provide a bronchotracheal access valve designed to eliminate the aforementioned drawbacks, and which is intrinsically safe.

According to the present invention, there is provided a bronchotracheal access valve for a bronchoaspiration apparatus, as claimed in the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

A non-limiting embodiment of the present invention will be described by way of example with reference to the accompanying drawings, in which:

FIG. 1 shows a three-dimensional assembly drawing of a bronchoaspiration apparatus;

FIG. 2 shows an exploded three-dimensional assembly drawing of the FIG. 1 bronchoaspiration apparatus;

FIG. 3 shows an enlarged three-dimensional view of a bronchotracheal access valve in accordance with the teachings of the present invention and forming part of the FIGS. 1 and 2 bronchoaspiration apparatus;

FIG. 4 shows a side view of the FIG. 3 bronchotracheal access valve;

FIG. 5 shows a plan view of a first configuration of FIGS. 3 and 4 bronchotracheal access valve;

FIG. 6 shows a plan view of a second configuration of FIGS. 3 and 4 bronchotracheal access valve;

FIG. 7 shows an exploded view of the first configuration of the bronchotracheal access valve in FIG. 5; and

FIG. 8 shows an exploded view of the second configuration of the bronchotracheal access valve in FIG. 6.

DETAILED DESCRIPTION

Number 10 in FIG. 1 indicates as a whole a bronchoaspiration apparatus connectable to a ventilation circuit (not shown).

Apparatus 10 comprises a vacuum control valve 11 connected mechanically to a catheter body 12.

Apparatus 10 also comprises a bronchotracheal access valve 13 representing the innovative part of apparatus 10 (see below).

A connecting member 14 completes apparatus 10.

More specifically, connecting member 14 comprises a conduit 14 a for connection to a patient (not shown); a conduit 14 b for connection to bronchotracheal access valve 13; and a conduit 14 c for connecting apparatus 10 to a ventilation circuit (not shown).

In the following description, only the details necessary for a clear understanding of the present invention will be described in detail, but hose of skill in the art will appreciate that the present invention will be described in detail, but hose of skill in the art will appreciate that the present invention encompasses variants not specifically discussed in detail herein.

Vacuum control valve 11 and connecting member 14 are known. Therefore, suffice it to say that vacuum control valve 11 comprises a cover 11 a marked with an arrow 11 b (indicated in the closed position in FIG. 1). When necessary, the operator applies finger pressure on cover 11 a and rotates it to set arrow 11 b to a vacuum source (not shown) to aspirate bronchial mucus. Only with arrow 11 b set to this position, can secretion be aspirated; in any other position of arrow 11 b, aspiration is prevented.

As shown in detail in FIG. 2, catheter body 12 comprises a transparent sleeve 15 made of easily deformable, tear-proof plastic material, and which protects a catheter 16 from contamination to and from an external environment. In know manner, catheter 16 comprises a number of depth marks 17 to enable the user to monitor insertion of suction catheter 16 (of minimum 5 Ch size) inside the tracheal/tracheostomic tube.

As shown in FIG. 2, between catheter body 12 and bronchotracheal access valve 13 are inserted a fitting 18 for guiding catheter 16, and a bushing 19 for securing transparent sleeve 15 to fitting 18.

As stated, the innovative part is defined by bronchotracheal access valve 13, which is shown in detail in the exploded views in FIGS. 2, 7, and 8.

All the component parts of bronchotracheal access valve 13 are made of transparent plastic material.

With reference to the accompanying drawings, bronchotracheal access valve 13 comprises a substantially disk-shaped first member 20, and a substantially cup-shaped second member 21 (FIGS. 2, 7, and 8).

Second member 21 in turn comprises a cup-shaped main body 22, from a surface 22 a (FIG. 4) from which projects a through conduit 23 (e.g. insertion means), for passage of a catheter 16. The through conduit 23 is fixed, in use, to fitting 18 (FIG. 1). A flush conduit 24 (e.g. flush means) projects also from the surface 22 a. Conduits 23, 24 are advantageously, though not necessarily, formed in one piece with main body 22.

As shown in FIGS. 1, 2, 7, and 8, a flush tube 25 is inserted inside conduit 24, and has a cap 26 connected to it by a tie 27.

As shown particularly in FIG. 7, main body 22 has 25 three weight-reducing holes 28 located 120° apart, and at each of which a respective tab 29 is formed by conveniently cutting an edge 22 b of main body 22.

The function of the three tabs 29 is explained below.

As shown in FIGS. 3, 4, 5, and 6, a channel 30 is integrated in the inner wall of conduit 23, originates at a point P1 at the bottom of conduit 23, and terminates at a point P2 (FIGS. 3 and 4).

The functions of channel 30 are explained below, in the section dealing with the operation of bronchotracheal access valve 13.

A surface 22 c of main body 22 has a locating pin 31 (FIG. 2) which fits inside a locating hole 32 formed in the center of first member 20 (FIGS. 5 and 6). The inner surface of edge 22 b has a pin 33, which, in use, engages a guide duct 34 (FIGS. 5, 6, 7, and 8) formed on an edge 20 a of first member 20, for the reasons explained in detail below.

For the time being, suffice it to say that pin 33 and guide duct 34 define a stop device.

As shown in FIGS. 2, 3, 4, 7, and 8, a through sleeve 35 (e.g. connecting means) projects from a surface 20 b of first member 20, and is connected, in use, to conduit 14 b of connecting member 14.

In addition to locating hole 32 and guide duct 34, a surface 20 c of first member 20 (FIGS. 7 and 8) also comprises a substantially semicircular duct 36.

Surface 20 c also comprises a number of ducts 37 for housing an elastomer seal 38.

Seal 38 obviously provides for hydraulically sealing duct 36 from the mouth of sleeve 35.

That is, seal 38 (e.g., a selective communication means), as will be seen, prevents the flush fluid from accidentally flowing from duct 36 to the mouth of sleeve 35.

During assembly, first member 20, second member 21, and seal 38 (inserted inside ducts 37) are “packed” tightly (FIGS. 7 and 8) together using the deformability of tabs 29 on second member 21, which grip onto edge 20 a of first member 20.

In other words, during assembly, main body 22 of second member 21 “clicks” onto first member 20 using the deformability of tabs 29 formed from edge 22 b and therefore made of plastic material.

In actual use, second member 21 can be rotated by the operator with respect to first member 20 in the direction indicated by arrow F1 (and about locating pin 31) to move bronchotracheal access valve 13 from a first configuration, shown in FIG. 5, to a second configuration, shown in FIG. 6. In the first configuration in FIG. 5, pin 33, integral with second member 21, is set to a limit position A along guide duct 34 in first member 20, and conduit 23 is aligned with sleeve 35, with conduit 14 b, with fitting 18, and with busing 19, so that catheter 16 can fit through conduit 23, sleeve 35, and conduit 14 b to the desired areas of the patient's body.

In the first configuration in FIG. 5, flush conduit 24 terminates at one end inside duct 36. However, since duct 36 in this configuration does not communicate hydraulically with conduit 23 or channel 30, the flush fluid, even if injected by the operator inadvertently into duct 36 through conduit 24, is also prevented by seal 38 from reaching conduit 23 or channel 30.

To flush an end portion 16 a (FIG. 2) of catheter 16, the operator simply withdraws catheter 16 to pull end portion 16 a out of sleeve 35 (FIG. 4), and rotates second member 21 with respect to first member 20 in the direction of arrow F1, so that pin 33 is set to a limit position B (FIG. 6) along guide duct 34, and one end of channel 30 is positioned on duct 36. Flush conduit 24 is also rotated in the direction of arrow F1, but a free end of it is still maintained contacting duct 36.

This therefore results in the FIG. 6 configuration, in which, flush fluid injected by the operator into flush conduit 24 flows along duct 36 (arrow F2 in FIGS. 4 and 6) into channel 30 and out at point P2 to flood conduit 23 and so flush end portion 16 a of catheter 16. It should be pointed out that, when second member 21 is rotated with respect to first member 20 in the direction of arrow Fl, surface 20 c of first member 20 (FIGS. 7 and 8) closes the end of conduit 23, thus preventing accidental backflow of the flush fluid from conduit 23 to the patient through sleeve 35 and conduit 14 b.

Once flushing is completed, the flush fluid is drained from conduit 23 by known drain systems.

Once end portion 16 a is flushed, the operator simply rotates second member 21 with respect to first member 20 in the opposite direction to arrow F1, and then pushes catheter 16 back into sleeve 35 and conduit 14 b to continue treatment of the patient.

As will be clear from the foregoing description, the main advantage of the bronchotracheal access valve, which is the main object of the present invention, lies in it being designed to only permit flushing of the end of the catheter in conditions ensuring the utmost safety of the patient. 

What is claimed is:
 1. A method comprising: removing a catheter from within a patient through a patient conduit; rotating a first member of a bronchotracheal access valve in a first direction with respect to a second member of the bronchotracheal access valve such that a catheter insertion conduit and a flush conduit of the bronchotracheal access valve are communicatively coupled to one another, and are not coupled to the patient conduit; and flushing a distal end of the catheter in the catheter insertion conduit with a fluid flowing through the flushing conduit and a duct, wherein the duct is configured to create selective fluid communication between the catheter insertion conduit and the flush conduit, and wherein a surface of the first member closes the patient conduit.
 2. The method of claim 1 wherein, the first member comprises the catheter insertion conduit and the flush conduit.
 3. The method of claim 1, wherein the second member comprises the patient conduit and at least partially defines the duct that communicatively couples the catheter insertion conduit and the flush conduit.
 4. The method of claim 1, wherein the duct is substantially semicircular.
 5. The method of claim 1, wherein the duct comprises a channel integrated in an inner wall of the catheter insertion conduit.
 6. The method of claim 1, wherein the bronchotracheal access valve comprises a seal between the first member and the second member
 7. The method of claim 6, wherein the seal comprises a first region that seals the duct in communication with the flush conduit from the patient conduit when the first member is rotated in a second direction and that seals the flush conduit and the catheter insertion conduit in fluid communication with one another from the patient conduit when the first member is rotated in the first direction.
 8. The method of claim 1 comprising; rotating the first member in a second direction with respect to the second member, such that the patient conduit and the catheter insertion conduit are aligned and in fluid communication with each other but not the flush conduit.
 9. The method of claim 8, wherein the second direction is opposite the first direction.
 10. The method of claim 1, wherein the bronchotracheal valve comprises a stopping feature that limits the rotation of the first member in the first direction and a second direction with respect to the second member, such that the catheter conduit is aligned with the duct and in fluid communication with the flush conduit when the first member is rotated in the first direction, and wherein the catheter conduit is aligned with the patient conduit when the first member is rotated in the second direction.
 11. A bronchotracheal access valve for a bronchoaspiration apparatus, the bronchotracheal access valve comprising: a first member comprising a patient conduit; and a second member comprising a catheter insertion conduit and a flush conduit, wherein an inner wall of the insertion conduit comprises a channel; a first duct formed in the first member, wherein the first duct creates selective fluid communication between the flush conduit and the insertion conduit, but not the patient conduit; and a stopping feature configured to stop rotation of the second member with respect to the first member at a first position such that the flush conduit and the channel are superposed on the first duct creating selective fluid communication between the insertion conduit and the flush conduit; and wherein the stopping feature is configured to stop rotation of the second member with respect to the first member at a second position such that a surface of the first member closes the channel to prevent fluid communication between the flush conduit and the insertion conduit.
 12. The valve of claim 11, wherein a seal is disposed between the first member and the second member
 13. The valve of claim 12, wherein the first member comprises a plurality of ducts for housing the seal.
 14. The valve of claim 12, wherein, in the second position, the flush conduit is sealed by the seal and the patient conduit is open.
 15. The valve of claim 12, wherein the seal comprises an elastomeric material.
 16. The valve of claim 11, wherein a radial inner surface of the second member comprises a protrusion configured to engage a second duct formed on an edge of the surface of the first member.
 17. The valve of claim 16, wherein the protrusion and the second duct define the stopping feature.
 18. The valve of claim 16, wherein the first duct and the second duct are semicircular.
 19. The valve of claim 11, wherein the second member comprises a protrusion that engages an opening centrally located on the first member such that the second member and the first member are properly aligned.
 20. The valve of claim 11, wherein the first member comprises a plurality of deformable tabs along an outer edge, wherein the deformable tabs snap onto the second member to connect the first member with the second member. 